BS EN ISO 14971:2007
Medical devices - Application of risk management to medical devices
- Standard No.
- BS EN ISO 14971:2007
- Release Date
- 2007
- Published By
- British Standards Institution (BSI)
- Status
- 2009-07
- Replace By
- BS EN ISO 14971:2009
- Latest
- BS EN ISO 14971:2019+A11:2021
- Scope
- ISO 14971:2007 specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls. The requirements of ISO 14971:2007 are applicable to all stages of the life-cycle of a medical device.
BS EN ISO 14971:2007 history
- 1970 BS EN ISO 14971:2019+A11:2021 Medical devices - Application of risk management to medical devices
- 2012 BS EN ISO 14971:2012 Medical devices. Application of risk management to medical devices
- 2009 BS EN ISO 14971:2009 Medical devices - Application of risk management to medical devices
- 2007 BS EN ISO 14971:2007 Medical devices - Application of risk management to medical devices
- 2001 BS EN ISO 14971:2001 Medical devices - Application of risk management to medical devices
